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QT9™ QMS FDA 21 CFR Part 820 Compliance Software

The FDA's quality system requirements are summed up in 21 CFR Part 820 which lays out the Current Good Manufacturing Practice of the manufacturing and distribution of medical devices. In order to get your FDA clearance you must have solid quality controls in place. Many medical device/bioMed companies out there are still relying on manual paper or Excel based systems to handle all of the FDA's requirements.

QT9™ Quality Management Software is a one stop FDA quality system compliance solution. QT9™ QMS is completely 21 CFR Part 11 compliant with electronic signatures and is validated after every release. QT9™ QMS is in line with the FDA QSRs to not only keep you in compliance with 21 CFR Part 820, but also cut down time spent managing your quality records. Let QT9™ QMS handle the burden of your FDA requirements and automate your management system making your organization more efficient and productive.

Are you regulated by the FDA? Ask us about our validation program!

Look below to see how QT9™ QMS stacks up against 21 CFR Part 820.

Requirement QT9™ QMS Module/Solution
Subpart B 820.20 – Management Responsibility QT9™ QMS Management Review Module
Subpart B 820.22 - Quality Audit QT9™ QMS Audit Management Module
Subpart B 820.25 - Personnel QT9™ QMS Training Module
Subpart C 820.30 – Design Controls QT9™ QMS ECR/ECN Module
Subpart D 820.40 – Document Controls QT9™ QMS Document Control Module
Subpart E 820.50 – Purchasing Controls QT9™ QMS Supplier Evaluation Module/QT9™ QMS Supplier Surveys Module/QT9™ QMS Corrective Action Module
Subpart G 820.70 – Production and Process Controls QT9™ QMS Inspections Module/Product Management
Subpart G 820.72 – Inspection, Measuring, and Test Equipment QT9™ QMS Calibration Module/QT9™ QMS Inspections Module
Subpart I 820.90 – Nonconforming Product QT9™ QMS Nonconforming Product Module/QT9™ QMS Corrective Action Module
Subpart J 820.100 – Corrective and Preventive Actions QT9™ QMS Corrective Action Module
Subpart M 820.198 – Customer Complaint Files QT9™ QMS Customer Feedback (Customer Complaints) Module